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The Variable Ventilation Trial (Part A) (VV (A))

25. august 2026 opdateret af: Rebecca Baron, Brigham and Women's Hospital

A Bayesian, Operationally Seamless Adaptive Phase 2A/2B, Open-label, Multi-center, Randomized, Two-part Trial to Evaluate the Safety, Efficacy, and Optimal Tidal Volume Distribution of Variable Ventilation (VV) in Participants Undergoing Mechanical Ventilatory Support for Acute Respiratory Distress Syndrome

The goal of this clinical trial is to learn if a breathing machine (ventilator) method called "variable ventilation" can help protect the lungs of adult patients with acute respiratory distress syndrome (ARDS) who need help breathing through a ventilator. In variable ventilation, the size of each breath given by the machine changes slightly from breath to breath, instead of staying the same size in every breath. The study has two parts, A (safety and feasibility) and B (efficacy). This entry will cover the part A (safety study).

The main questions part A aims to answer are:

  1. Is variable ventilation safe to use in adults with ARDS?
  2. Is it feasible to deliver this method of ventilation to patients?

Researchers will compare variable ventilation to the standard breathing machine method used today to see if variable ventilation is safe and feasible.

Participants will be placed on an FDA approved ventilator that can deliver conventional mechanical ventilation and variable ventilation. Participants will:

  • Have a period of stabilization on conventional ventilation, followed by 24 hours of variable ventilation, followed by 24 hours of conventional ventilation.
  • Be checked regularly for breathing, oxygen levels, lung function, and plasma biomarkers.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
        • Kontakt:
    • Massachusetts
    • New York
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239-3098
        • Oregon Health & Science University
    • Utah

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Patients ≥21 years old admitted to the Surgical, Trauma, Burn, Coronary or Medical ICUs with ARDS according to the Berlin criteria [50] and requiring mechanical ventilation will be eligible for inclusion.
  2. Not more than 96 hours of mechanical ventilation before randomization
  3. Anticipated need for at least 48 more hours of controlled mechanical ventilation

  4. Intubated and mechanically ventilated for ARDS according to the Berlin criteria

    • Hypoxemia of acute onset, within the past 7 days
    • Mild or moderate hypoxemia, PaO2/FiO2 ratio 100 - 300 mm Hg
    • Presence of a risk factor for ARDS
    • Respiratory failure not fully explained by cardiac failure or fluid overload
    • Bilateral opacities not explained by effusions, lobar collapse, or nodules

Exclusion Criteria:

Demographic

  1. Age less than 21 years
  2. Pregnant or breastfeeding
  3. Prisoner
  4. Concurrent participation in another investigational drug study
  5. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if they would receive all supportive care except for attempts at resuscitation from cardiac arrest)
  6. No consent or inability to obtain consent or appropriate legal representative not available
  7. Physician refusal to allow enrollment in the trial
  8. Moribund patient not expected to survive 24 hours
  9. Treating team unwilling to use ARDS network low tidal volume strategy or variable ventilation mode
  10. Use, or planned use of ECMO
  11. Stroke (ischemic or hemorrhagic) or traumatic brain injury (TBI) within the prior 3 months
  12. Burns > 40% total body surface area (TBSA)
  13. Severe airway inhalational injury
  14. Diffuse alveolar hemorrhage

  15. Any of the following hallmarks of Severe COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade 3 or 4

    1. FEV1 < 50% predicted
    2. Resting arterial blood gas values PaO2<55, SaO2<88%, or PaCO2>55
    3. Home invasive or non-invasive ventilation other than for sleep apnea
    4. Cor Pulmonale
    5. Candidate for, or has received, lung volume reduction surgery, bronchoscopic intervention to reduce end-expiratory lung volume, or lung transplantation

  16. Any of the following cardiac problems:

    1. Acute myocardial infarction (MI) or acute coronary syndrome within the last 90 days
    2. Coronary artery bypass graft (CABG) surgery within 30 days
    3. Angina pectoris, or use of nitrates, with activities of daily living
    4. Cardiopulmonary disease classified as NYHA class IV

    Physiological Exclusions

  17. Evidence of current barotrauma (e.g., pneumothorax, pneumomediastinum, or subcutaneous emphysema)
  18. Hemodynamic instability defined by inability to maintain a mean arterial pressure > 60 mm Hg.
  19. Other respiratory instability PEEP ≥18 cmH2O, suctioning more than hourly, Pplateau > 35 cm H2O, severe respiratory acidosis pH<7.25.
  20. Increased ICP > 20 cmH2O or mechanism of injury leading to concern for increased ICP
  21. Active bleeding with hemodynamic instability.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Variable Ventilation
Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS. The variable ventilation (VV) strategy will be implemented on a commercially available ventilator.
Enhed: Variable Ventilation
Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS.
Placebo komparator: Conventional Ventilation
Standard strategy of mechanical ventilation based on constant size low tidal volume implemented on a commercially available ventilator.
Enhed: Conventional Ventilation
Strategy of mechanical ventilation based on delivery of a constant size low tidal volume.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Barotrauma
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Worsening Hypoxemia
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Worsening ventilation
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
New onset arrhythmia requiring cardioversion
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Hemodynamic instability
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
ST-segment elevation myocardial infarction
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Self-extubation
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Stroke
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Death
Maximum of 24 hours of VV

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lung mechanics
Tidsramme: Every 12 hours to maximum of 24 hours of VV
Lung compliance, airways resistance, peak and plateau pressures
Every 12 hours to maximum of 24 hours of VV
Gas exchange
Tidsramme: Every 12 hours to maximum of 24 hours of VV
SpO2, PaO2/FiO2 ratio, oxygenation index, dead space, and lung injury score.
Every 12 hours to maximum of 24 hours of VV
Feasibility of VV implementation.
Tidsramme: Every 12 hours during 24 hours of VV
Qualitative feedback from Research and Clinical staff of the device and implementation in the ICU setting.
Every 12 hours during 24 hours of VV

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Brigham and Women's Hospital

Samarbejdspartnere

Boston University
University of Alabama at Birmingham
Oregon Health and Science University
Baystate Medical Center

Efterforskere

  • Ledende efterforsker: Rebecca Baron, MD, Brigham and Women's Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. februar 2027

Primær færdiggørelse (Anslået)

1. februar 2031

Studieafslutning (Anslået)

31. august 2031

Datoer for studieregistrering

Først indsendt

25. august 2026

Først indsendt, der opfyldte QC-kriterier

25. august 2026

Først opslået (Faktiske)

27. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026P001935
  • HT94252510768 (Andet bevillings-/finansieringsnummer: DOD)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

We will only be sharing data in agregate.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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